Your browser does not support JavaScript! DECOLORIZED IODINE (IODIDES TINCTURE) LIQUID [DENISON PHARMACEUTICALS, INC.]
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DECOLORIZED IODINE (iodides tincture) liquid
[Denison Pharmaceuticals, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active Ingredient

Ethyl Alcohol 48.0%

Purpose

First aid antiseptic

Use      

first aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

For external use only

Flammable, keep away from fire or flame.

When using this product 

do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

Stop use and consult a doctor 

if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions  

  • clean the affected area.
  • apply a small amount of this product on the area 1 to 3 times daily.
  • may be covered with a sterile bandage
  • if bandaged, let dry first.

Other Information 

store at room temperature

Inactive ingredients 

ammonium hydroxide, iodine, potassium iodide, and purified water

PRINCIPAL DISPLAY PANEL

NDC 0295-1183-31

Decolorized Iodine

Iodides Tincture

FIRST AID ANTISEPTIC

Contents 1 FL. OZ. (30mL)

PRINCIPAL DISPLAY PANEL
NDC 0295-1183-31
Decolorized Iodine
Iodides Tincture
FIRST AID ANTISEPTIC
Contents 1 FL. OZ. (30mL)

DECOLORIZED IODINE 
iodides tincture liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0295-1183
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (ALCOHOL) ALCOHOL0.48 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
AMMONIA 
IODINE 
POTASSIUM IODIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-1183-3130 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33107/01/1964
Labeler - Denison Pharmaceuticals, Inc. (001207208)

Revised: 12/2009
 
Denison Pharmaceuticals, Inc.

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